111 Intensive 10-day Workshop on Model-informed Drug Development - April 15-26, 2024 | ONLINE

Content
10 modules
Instructor
Kelly Turton
Released
04 Jan 2024
Price
£3,400.00

Description

April 15-26, 2024 | ONLINE 

Live sessions typically run for 3hrs per day with assignments to complete out of session.

Incorporating population variability into mechanistic prediction of PK and modeling PK/PD
The model-informed approach to various aspects of drug development is rapidly being adopted by the leading pharmaceutical
companies. The Simcyp workshops focus on the optimal use of compound-specific in vitro and in vivo data together with system specific information related to humans to simulate and understand drug behavior in various target populations. This integrated approach informs decisions related to Investigational New Drugs and assists with the conduct and optimal design of clinical studies. The ultimate aim is to better understand drug PK/PD properties, reduce the cost and time of drug development, improve the quality of regulatory submissions, and eventually implement precision medicine.

Live Online Courses

There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.

Objectives

Delegates will learn how to simulate and predict:

• Metabolic drug clearance (CL)
• Metabolic drug-drug interactions (DDIs)
• Gut first-pass metabolism
• Oral drug absorption incorporating food effects and the impact of dosage form
• Effect of transporters and enterohepatic recirculation on kinetics and DDIs
• Drug distribution to different organs
• Population variability in drug concentration-time profiles
• Variation in kinetics in specific populations (pediatrics, ethnic groups, various disease populations)
• Modeling of therapeutic proteins
• Pharmacodynamic effects of different compounds
• Time-course of drug in plasma that fits observed clinical data (achieved by combining fitting techniques with IVIVE, PBPK and drug-specific in vitro data)

Certificate

By completing/passing this course, you will attain the certificate Certificate of Completion - Full Eng

1.
Pre Course Questionnaire - Your experience, expectations and area of interest, an optional survey to take prior to the course.
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2.
Pre Workshop Reading List, A selection of publications related to the Simcyp Simulator and model-informed drug development.
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3.
A beginners Introduction to the Simcyp Simulator & other useful Demos
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4.
Workshop Agenda
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5.
Simcyp Simulator Download instructions (Amazon Workspaces download)
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6.
Live Sessions will be via TEAMS
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7.
Slide Decks & files for Loading
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8.
Hands on Materials / Questions & Answers / Office Hour Discussion Slides
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9.
Session Recordings & Key Learning Points (Office Hour Slides)
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10.
Survey, please complete for Certificate of completion
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